Impact of Child Positioning on Pain During a Lumbar Puncture
NCT ID: NCT02834156
Last Updated: 2018-03-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
28 participants
INTERVENTIONAL
2015-06-30
2017-08-23
Brief Summary
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It's a prospective, monocentric, randomized, open-label, cross-over study. Inclusion period is one year, and number of inclusions forecasted is about 30. Each patient will have one LP in a seated position and one in a lying position.
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Detailed Description
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In hematological malignancies, lumbar punctures are particularly frequent as the therapy processes. Despite a good analgesia, this repeated procedure can generate pain, anxiety, apprehension leading to an increasing difficulty in the procedure realization.
Two positions are possible to carry out lumbar puncture: seated or lying position.
The main goal of this study is to assess the impact of the child positioning during the lumbar puncture process in term of pain, anxiety and stress.
This study is a prospective, monocentric, randomized, open-label, cross-over study. Inclusion period is 1 year, 30 patients will be included from 2 to 18 years old.
Each patient will have 2 LP one in seated and one in lying position in a specific order determined by randomization.
All data regarding pain and anxiety will be collected the day of LP. Patients will be re contacted 48 hours and 15 days after LP procedure in order to evaluate complications such post-lumbar puncture syndrome or hematoma. The main analysis will be done on intent-to-treat-analysis basis and will compare pain intensity between the two groups.
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
OTHER
NONE
Study Groups
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LP in a seated position then LP in a lying position
Patients will have first a lumbar puncture (LP) in a seated position then a LP in a lying position
LP in a seated position then LP in a lying position
LP in a lying position then LP in a seated position
Patients will have first a lumbar puncture (LP) in a lying position then a LP in a seated position
LP in a lying position then LP in a seated position
Interventions
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LP in a seated position then LP in a lying position
LP in a lying position then LP in a seated position
Eligibility Criteria
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Inclusion Criteria
* Patients requiring at least 2 therapeutic lumbar punctures
* Patients able to receive analgesic procedure according to 20005 good practices recommendation
* Presence of one parent during LP procedure
* Child able to use assessment scales
* LP realized with a 20 G needle
* Platelets \> 50000
* Child with prior clinical examination
* Affiliated to a health care insurance regimen
Exclusion Criteria
* Lumbar puncture contraindication
* Patient or parent opposition to second LP realization in the required position
* Clotting trouble on LP day not allowing the LP procedure
2 Years
18 Years
ALL
No
Sponsors
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Centre Hospitalier Universitaire de Nice
OTHER
Responsible Party
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Locations
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CHU de Nice
Nice, , France
Countries
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Other Identifiers
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15-PP-05
Identifier Type: -
Identifier Source: org_study_id
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